CARE-CITE R21: Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT04040751

Collaborator

National Institute of Nursing Research (NINR) (NIH)

Enrollment

Location

Arms

28.4

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A novel, web-based carepartner focused intervention (CARE-CITE) is designed to foster problem solving and skill building while facilitating carepartner engagement during upper extremity functional activities in the home setting. The proposed study will evaluate the application of the CARE-CITE intervention paired with usual and customary care during the sub-acute stroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: CARE-CITE Behavioral: Standard of care	N/A

Detailed Description

Stroke is a leading cause of long-term disability and to date, research has placed little emphasis on how to integrate carepartners (family members) into the rehabilitation process without increasing negative carepartner outcomes.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke

Actual Study Start Date :

Aug 9, 2019

Actual Primary Completion Date :

Dec 21, 2021

Actual Study Completion Date :

Dec 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CARE-CITE Carepartner This study arm consists of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8.	Behavioral: CARE-CITE The primary CARE-CITE components will be education via web platform. CP completes 6 online CARE-CITE modules (15-30-minute sessions each). Modules include demonstration videos and instructive content covering following areas: principles of functional task practice (i.e., activities of daily living such as eating, grooming, or leisure/vocational activities), adaptation of tasks, and importance of progression of challenging tasks to drive neuroplasticity (i.e., increasing numbers of practice repetitions or weight of objects lifted). Underpinning the content is the concept of autonomy support, with examples of fostering empathy, problem solving, instruction in the use of non-controlling language with role playing situations and the importance of creating choice in activities.
Active Comparator: Control Carepartners Carepartners (CP) receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The CP will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups.	Behavioral: Standard of care The CP will receive a CP support brochure with general caregiving information including website resources to mimic web interaction of intervention group (e.g., stroke caregiver resource site).
Experimental: CARE-CITE Stroke Survivor This study arm consists of stroke survivors of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8.	Behavioral: CARE-CITE The primary CARE-CITE components will be education via web platform. CP completes 6 online CARE-CITE modules (15-30-minute sessions each). Modules include demonstration videos and instructive content covering following areas: principles of functional task practice (i.e., activities of daily living such as eating, grooming, or leisure/vocational activities), adaptation of tasks, and importance of progression of challenging tasks to drive neuroplasticity (i.e., increasing numbers of practice repetitions or weight of objects lifted). Underpinning the content is the concept of autonomy support, with examples of fostering empathy, problem solving, instruction in the use of non-controlling language with role playing situations and the importance of creating choice in activities.
Active Comparator: Control Stroke Survivors Stroke survivors (SS) receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The CP will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups.	Behavioral: Standard of care The CP will receive a CP support brochure with general caregiving information including website resources to mimic web interaction of intervention group (e.g., stroke caregiver resource site).

Outcome Measures

Primary Outcome Measures

Change in Carepartner (CP) Depression using Center for Epidemiologic Studies - Depression (CES-D) Scale score [Baseline and 2 months post-intervention]
CES-D is 20-item, Likert-type scale (range 0-none/rare to 3-most/all of the time). The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Change in Carepartner (CP) quality of life using Short Form Health Survey (SF-36) Scale score [Baseline and 2 months post-intervention]
SF-36 is a 36-item Likert-type scale,mental health domain. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change in Stroke Survivor (SS) Upper Extremity Function using Wolf Motor Function Test (WMFT) score [Baseline and 2 months post-intervention]
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks. The first 6 items involve timed functional tasks, items 7 and 14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The items are rated on a 6-point scale. Lower scores are indicative of lower functioning levels.
Change in SS Upper Extremity Function using Motor Activity Log (MAL) score [Baseline and 2 months post-intervention]
Motor Activity Log is 30-item questionnaire with Likert-type scale. The MAL adopts a 6-point ordinal scale, although patients can attribute a half-score, resulting in 11-point Likert scales with specified anchoring definitions at 6 points. High core represents high quality upper extremity use.
Change in SS Quality of Life using Stroke Impact Scale (SIS) score [Baseline and 2 months post-intervention]
Stroke Impact Scale (SIS) 59-items are broken down into eight domains: strength, hand function, mobility, activities of daily living, emotion, memory, communication, social participation. Domains are scored on a metric of 0 to 100, with higher scores indicating better self-reported health.

Secondary Outcome Measures

Change in Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score [Baseline and 2 months post-intervention]
The Family Care Climate Questionnaire (FCCQ) for carepartners is 14-item questionnaire asking about the carepartners' experiences with the strokes survivor in relation to their rehabilitation activities. Each item is rated on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true). Item scores are averaged to provide an overall score between 1 and 7 where higher scores indicate the carepartner thinks they are providing high autonomy support to the stroke survivor.
Change in Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score [Baseline and 2 months post-intervention]
The Family Care Climate Questionnaire (FCCQ) for stroke survivors is 14-item questionnaire asking about experiences with family members in relation to rehabilitation activities. Each item is rated on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true). Item scores are averaged to provide an overall score between 1 and 7 where higher scores indicate the stroke survivor perceives receiving high autonomy support from the carepartner.
Change in CP Family Conflict using Family Caregiver Conflict Scale (FCCS) score [Baseline and 2 months post-intervention]
The FCCS is a unidimensional, Likert-type scale composed of 15 items. Each item response is in a Likert-type format with participants indicating their agreement with the item with 1 "not true at all" to 7 "very true." Item scores are summed and higher scores represent higher levels of conflict within a family.
Change in SS Upper Extremity (UE) Self Efficacy using Confidence in Hand and Movement Scale (CAHM) score [Baseline and 2 months post-intervention]
Confidence in Hand and Movement Scale (CAHM) is 20-item (scale 0-100) upper extremity confidence for functional tasks. High scores represent high confidence.
Family Assessment Device (FAD) Scale Score [Baseline]
The 12-item General Family Functioning scale from the McMaster Family Assessment Device measures general family functioning. The Family Assessment Device is recommended as an assessment measure for families of stroke survivors. Higher scores indicate ineffective family functioning.
Change in Caregiver Strain assessed by the Caregiver Strain Index (CSI) [Baseline and 2 months post-intervention]
The CSI is a 13-question tool that measures strain related to care provision. There is at least one item for each of the following major domains: Employment, Financial, Physical, Social and Time. Positive responses to seven or more items on the index indicate a greater level of strain. Scoring ranges from 0 to 26, with 0 indicating no caregiver strain and 26 indicating extreme strain.
Change in Bakas Caregiving Outcomes Scale (BCOS) Score [Baseline and 2 months post-intervention]
The BCOS is a unidimensional scale based on 10 items and addresses changes in caregiving social functioning, subjective well-being and physical health. Participants respond to statements on a 7-point Likert scale (1=changed for the worst, 7=changed for the best).
Upper Extremity Impairment assessed by the Fugl-Meyer Assessment (FMA) [Baseline]
Upper extremity impairment will be assessed by the Fugl-Meyer Assessment (FMA). The FMA evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale. The maximum score is 66 points. Higher score indicates higher arm function.
Change in stroke survivor quality of life assessed by Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities [Baseline and 2 months post-intervention]
Stroke survivor quality of life and social participation will be assessed by the Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities, an 8- item, Likert-type scale involving satisfaction in the last 7 days. All Neuro-QoL scores should be presented as T-scores. The T-score is the standardized score with a mean of 50 and standard deviation of 10. Raw scores should only be reported for uncalibrated items (i.e., item pools). Having T-scores in publications facilitates comparisons between studies.
Change in Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression- Short Form 6a Score [Baseline and 2 months post-intervention]
Depressive symptoms among caregivers will be assessed with the 6-item PROMIS Depression- Short Form 6a instrument. Responses are given on a scale from 1 to 5 where 1 = never and 5 = always. Total scores range from 6 to 30 where higher scores indicate greater feelings of depression.
Change in Upper Extremity Function-Fine Motor/ ADL will be assessed by Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) [Baseline, 2 months post-intervention]
The Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) is an 8-item upper extremity function measure, Likert-type scale All Neuro-QoL scores should be presented as T-scores. The T-score is the standardized score with a mean of 50 and standard deviation of 10. Raw scores should only be reported for uncalibrated items (i.e., item pools).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria for Stroke Survivors (SS):

1-3 months post ischemic or hemorrhagic event
discharged from inpatient neurologic rehabilitation to their home
have minimal to moderate UE deficits (actively initiate 20 degrees of wrist and 10 degrees of finger extension)
no severe cognitive deficits (Mini -mental test >24)
no physician determined major medical problems that would limit participation in outpatient therapy